Mask

ABSTRACT

A mask for delivery of respiratory therapy to a patient may include one or more of the following improvements: rigidizer provided to headgear strap, locking clip/clip receptacle headgear connection, keyed headgear buckles, lotion dispenser on frame, rotatable prongs to adjust orientation, alignment indicators provided to prong, cushion and/or frame, chin flap with bellows arrangement, vent holes positioned away from gas entry port, and vent holes to direct washout gas at an angle.

CROSS-REFERENCE TO APPLICATION

This application claims the benefit of U.S. Provisional Application No.60/935,268, filed Aug. 2, 2007, which is incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a mask for delivery of respiratorytherapy to a patient. Examples of such therapies are Continuous PositiveAirway Pressure (CPAP) treatment, Non-Invasive Positive PressureVentilation (NIPPV), and Variable Positive Airway Pressure (VPAP). Thetherapy is used for treatment of various respiratory conditionsincluding Sleep Disordered Breathing (SDB) such as Obstructive SleepApnea (OSA).

BACKGROUND OF THE INVENTION

A known mask is commercially sold under the name of HYBRID™ by Respcare,Inc. and one or more portions of the mask are described in U.S. PatentPublication No. 2006/0124131, published Jun. 15, 2006, and/or at thewebsite www.hybrid-mask.com.

SUMMARY OF THE INVENTION

One aspect of the present invention relates to improvements and/oralternative arrangements of HYBRID™ mask to enhance respiratory therapy.

Another aspect of the invention relates to a mask including a frame, afacial and nasal interface provided to the frame, and headgear providedto the frame to maintain the mask in a desired position on the patient'sface. The headgear includes at least one strap and a buckle provided tothe strap. The buckle includes an opening adapted to engage a postprovided on the frame. The opening and/or the post includes a keyedportion structured to prevent rotation of the buckle with respect to thepost when the buckle is engaged with the post.

Another aspect of the invention relates to a mask including a frame, afacial and nasal interface provided to the frame, and a lotion dispenseror moisturizer provided to frame and adapted to dispense lotion forlubricating and/or moisturizing the facial and/or nasal interface.

Another aspect of the invention relates to a mask including a frame, acushion provided to the frame and adapted to form a seal around anexterior of the patient's mouth in use, and nasal prongs provided to thecushion and adapted to from a seal with the patient's nasal passages inuse. Each of the nasal prongs is adapted to rotate relative to thecushion to change the angle at which the nasal prong extends withrespect to the cushion.

Another aspect of the invention relates to a mask including a frame, acushion provided to the frame and adapted to form a seal around anexterior of the patient's mouth in use, and a chin portion or chin flapprovided to the cushion and adapted to engage the patient's chin in use.The chin portion or chin flap includes a bellows arrangement structuredto allow movement of the patient's chin in use.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIGS. 1-1 to 1-12 are various views of a known mask commercially soldunder the name of HYBRID™;

FIGS. 2-1 to 2-9 illustrate headgear according to alternativeembodiments of the present invention;

FIGS. 3-1 to 3-4 illustrate headgear connection according to alternativeembodiments of the present invention;

FIGS. 4-1 to 4-2 illustrate frames according to alternative embodimentsof the present invention;

FIGS. 5-1 to 5-2 illustrate nasal prongs according to alternativeembodiments of the present invention;

FIG. 5-3-1 illustrates a nasal prong of the HYBRID™ mask;

FIGS. 5-3-2 and 5-3-3 illustrate a nasal prong according to anembodiment of the present invention;

FIGS. 5-4 to 5-8 illustrate nasal prongs according to alternativeembodiments of the present invention;

FIG. 6-1-1 illustrates a cushion profile of the HYBRID™ mask;

FIG. 6-1-2 illustrates a cushion profile according to an embodiment ofthe present invention;

FIGS. 6-2 to 6-3 illustrate cushions according to alternativeembodiments of the present invention;

FIGS. 7-1 to 7-3 illustrate elbow assemblies according to alternativeembodiments of the present invention; and

FIGS. 8-1 to 8-4 illustrate vent arrangements according to alternativeembodiments of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following includes descriptions of several illustrated embodimentsof the present invention, which may share common characteristics andfeatures. It is to be understood that one or more features of any oneembodiment may be combinable with one or more features of the otherembodiments. In addition, each single feature or combination of featuresin any of the embodiments may constitute an additional embodiment.

Each illustrated embodiment includes features that may be adapted foruse and/or incorporated into the embodiments and/or components of theHYBRID™ mask, the mask described in U.S. Patent Publication No.2006/0124131, published Jun. 15, 2006, and/or at the websitewww.hybrid-mask.com, as would be apparent to those of ordinary skill inthe art. The HYBRID™ mask, U.S. Patent Publication No. 2006/0124131, andthe website www.hybrid-mask.com are each incorporated herein byreference in its entirety.

While each illustrated embodiment is described as being implemented intoa HYBRID™ mask, a mask of the type described in U.S. Patent PublicationNo. 2006/0124131, and/or a mask of the type described at the websitewww.hybrid-mask.com, each illustrated embodiment may be implemented intoother masks, e.g., full-face mask, mouth mask, nasal mask, nasal prongs,nozzles, nare seals, and/or cannulae.

1. Known Mask

FIGS. 1-1 to 1-12 illustrate a known mask 10 commercially sold under thename of HYBRID™ and one or more portions of the mask are described inU.S. Patent Publication No. 2006/0124131 and/or at the websitewww.hybrid-mask.com. As illustrated, the mask 10 includes a ventilationinterface or frame 12, a cushioned facial interface or cushion 14provided to the frame 12 and adapted to form a seal around an exteriorof the patient's mouth in use, a nasal interface or nasal prongs ornasal pillows 16 provided to the cushion 14 and adapted to from a sealwith the patient's nasal passages or nares in use, an elbow assembly 18provided to the frame 12 and adapted to be connected to an air deliverytube that delivers breathable gas to the patient, and headgear 20removably attached to the frame 12 to maintain the mask 10 in a desiredposition on the patient's face.

2. Improvements to Known Mask

The following embodiments describe improvements and/or alternativearrangements of the HYBRID™ mask to enhance respiratory therapy.

2.1 Headgear

The headgear 20 of the HYBRID™ mask is constructed of a soft, flexiblematerial and includes upper side straps 22 that pass over the patient'sear's, lower side straps 24 that pass below the patient's ear's, aVelcro® adjustable overhead strap 26 that passes over the top of thepatient's head, and upper and lower rear straps 28, 29 that pass behindthe patient's head and neck (e.g., see FIGS. 1-1, 1-2, and 1-6).

2.1.1 Rigid Element

In an alternative embodiment, as shown in FIG. 2-1, a rigid element orrigidizer 30 may be provided to each upper side strap 22 and/or eachlower side strap 24 to improve stability of the mask 10 on the patient'sface, e.g., vertical stability. In addition, the rigid element 30 may bestructured to orient force vectors in the correct direction to providecomfortable sealing. The rigid element 30 may be constructed of a rigidor semi-rigid material, e.g., nylon or plastic, and may be attached tothe strap 22, 24 in any suitable manner, e.g., stitching, welding,gluing, or mechanically fixed.

Exemplary embodiments of such a rigid element provided to a headgearstrap is disclosed in U.S. Pat. No. 6,907,882 and U.S. application Ser.No. 10/781,929, filed Feb. 20, 2004, each of which is incorporatedherein by reference in its entirety.

2.1.2 Velcro® Removal

In an alternative embodiment, as shown in FIG. 2-2, the Velcro®adjustment on the overhead strap 26 may be removed and the respectiveheadgear strap portions attached to one another, e.g., sewn together, tocreate a one size fits all headgear. This arrangement may simplifyheadgear adjustment.

An exemplary embodiment of such headgear is disclosed in PCT ApplicationNo. PCT/AU2006/000770, filed Jun. 6, 2006, which is incorporated hereinby reference in its entirety.

2.1.3 Lower Rear Strap Positioning

In an alternative embodiment, the lower rear strap 29 (see FIG. 1-6)that passes behind the patient's neck may be moved from that location.That is, the lower rear strap 29 may be arranged to pass behind a lowerportion of the patient's head and above the patient's neck, as shown inFIG. 2-3. This arrangement would prevent the mask from pulling off inuse, e.g., when the patient looks upwards.

An exemplary embodiment of such lower strap arrangement is disclosed inU.S. patent application Ser. No. 10/433,779, filed Nov. 13, 2003, whichis incorporated herein by reference in its entirety.

2.1.4 Other Headgear Alternatives

In an alternative embodiment, one or more of the headgear straps may beconstructed of a more elastic material, e.g., the upper and/or lowerside straps 22, 24.

In another alternative embodiment, Velcro® joints may be incorporatedinto one or more straps of the headgear 20 so that different parts ofthe headgear 20 could be aligned in different ways. For example, Velcro®joints 31 may be incorporated into the upper and/or lower rear straps28, 29 to allow adjustment of the length and/or angle of the upperand/or lower rear straps 28, 29 as shown in FIG. 2-4.

In another alternative embodiment, the upper side straps 22 and/or theupper rear strap 28 may be configured such that there is more spacebetween the strap and the patient's ears, e.g., move upper side straps22 away from the patient's ears as shown in FIG. 2-5.

In another alternative embodiment, one or more straps of the headgear 20may include a relatively soft cover, sock, or pad, e.g., constructed orfoam or gel, to improve comfort and/or aesthetics. The cover, sock, orpad may be attachable and retrofittable to the headgear straps. In anembodiment, the cover, sock, or pad is especially provided near thepatient's eyes and/or cheeks. For example, FIG. 2-6 illustrates covers33 provided to portions of the upper and lower side straps 22, 24.

In another alternative embodiment, as schematically shown in FIG. 2-7,the headgear 20 may include a pair of side straps 32 adapted to connectto the frame 12, and each side strap 32 forks into upper and lower sidestraps 22, 24 such as those described above.

In another alternative embodiment, an outrigger may be incorporated intothe headgear 20 and/or frame 12 to help stabilize the frame 12 on thepatient's face.

In another alternative embodiment, as shown in FIG. 2-8, the headgearstrap vectors may be changed, e.g., move lower side straps 24 up towardsupper side straps 22 to change strap vector of lower side straps 24. Inan embodiment, the strap vectors may be adjustable such as thosedescribed in U.S. Pat. No. 6,907,882, which is incorporated herein byreference in its entirety.

In another alternative embodiment, as shown in FIG. 2-9, a strap orsling 34 may be attached to the frame 12 and adapted to engage thepatient's nose, e.g., nasal bridge region or tip, to prevent downwardmovement of the mask in use.

2.2 Headgear Connection

The upper and lower side straps 22, 24 of the HYBRID™ headgear 20 eachinclude a Velcro® tab 40 that engages the remainder of the strap 22, 24to secure a buckle 42 in place. Each buckle 42 is adapted to engage arespective post 44 (e.g., mushroom-shaped post) on the frame 12 tosecure the headgear 20 to the frame 12. Specifically, each buckle 42 isinterlocked with a respective post 44 by first moving the buckle 42adjacent the respective post 44 such that the respective post 44 extendsthrough a larger opening in the buckle 42, and then moving the buckle 42into engagement with the post 44 to interlock the post 44 with a smalleropening in the buckle 42 (e.g., see FIGS. 1-3, 1-7, and 1-8).

2.2.1 Quick Release

In an alternative embodiment, as shown in FIG. 3-1, a quick releaserip-cord mechanism, extension member, or finger tab 46 may be providedon the end of one or more of the buckles 42 to facilitate engagementand/or disengagement of each buckle 42 with the respective post 44 onthe frame 12. The finger tab 46 may be rigid or flexible. In use, thefinger tab 46 may be pulled to move the respective post 44 into thelarger opening in the buckle 42, thereby allowing quick release ordisengagement of the buckle 42 from the respective post 44. That is, thefinger tab 46 allows the buckle 42 to be levered out of the respectivepost 44. In an embodiment, the free end of the finger tab 46 may includea ball-like protrusion 47 to facilitate grip.

An exemplary embodiment of such a finger tab is disclosed in U.S. patentapplication Ser. No. 10/584,711, filed Jun. 26, 2006, which isincorporated herein by reference in its entirety.

2.2.2 Extended Buckle

In an alternative embodiment, as shown in FIG. 3-2, the buckles 42provided to the upper and/or lower side straps 22, 24 may be extended inlength to improve stability of the mask 10 on the patient's face.

2.2.3 Locking Clip and Clip Receptacle

In an alternative embodiment, the buckle/post headgear connection of theHYBRID™ mask 10 may be replaced by locking clips, e.g., spring-loadedclip, adapted to engage respective clip receptacles provided to theframe. Exemplary clip arrangements are described in PCT Application No.PCT/AU2006/000770, filed Jun. 6, 2006, and U.S. Pat. Nos. 6,374,826 and6,907,882, each of which is incorporated herein by reference in itsentirety.

In an embodiment, the locking clip may be configured to lock into atleast one configuration or direction, e.g., lockable angular adjustment.

In another embodiment, each side of the frame may include only oneclip/receptacle headgear connection (e.g., use with headgear shown inFIG. 2-7).

In another embodiment, the locking clip and/or clip receptacle mayinclude a ratcheting arrangement to allow indexed rotational adjustment.

In another embodiment, the clip receptacle regions of the frame may beconstructed of a malleable material to allow the clip receptacles to bepositioned at different angles. In yet another embodiment, the clipreceptacle regions of the frame may include a lockable ball joint toprovide limited movement of the clip receptacles.

2.2.4 Other Headgear Connection Alternatives

In an alternative embodiment, the buckle and/or post may be keyed toprevent rotation of the buckle when attached to the post. Thisarrangement will maintain the headgear straps in a particularorientation or direction. For example, FIG. 3-3 illustrates a buckle 42wherein the smaller opening includes a keyed portion 35 that is adaptedto interlock with a keyed post 37 provided to the frame, thereby allowedthe buckle 42 to rotate and lock into a desired position.

In an alternative embodiment, a peg or post may be provided on aheadgear strap that is adapted to engage within a respective holeprovided to the frame.

In an alternative embodiment, a press-button quick release mechanism maybe incorporated into the headgear connection, e.g., such as thatdescribed in Australian Patent Application No. AU 2005100738 A4, filedSep. 8, 2005, which is incorporated herein by reference in its entirety.

In an alternative embodiment, a spring-biased pull tab quick releasemechanism may be incorporated into the headgear connection.

In an alternative embodiment, as shown in FIG. 3-4, a rotatable buckle45 may be coupled to both upper and lower side straps 22, 24. The buckle45 may engage a keyed post 49 having protrusions 51 adapted to engagewith corresponding recesses 48 in the buckle 45 and provide indexedincremental rotational adjustment.

2.3 Frame

The frame 12 of the HYBRID™ mask 10 includes a main body 50 having a gasentry port 52 adapted to connect to the elbow assembly 18. The frame 12also includes supplemental oxygen ports 54, vent holes 56, and posts 44adapted to engage buckles 42 provided to the headgear 20 (e.g., seeFIGS. 1-3 to 1-5 and 1-9).

2.3.1 Frame Alternatives

In an alternative embodiment, as shown in FIG. 4-1, the frame 12 mayinclude a lotion dispenser (e.g., pocket) or moisturizer 58, e.g.,positioned between the prongs 16 in use. The lotion dispenser ormoisturizer 58 may be adapted to dispense lotion for lubricating and/ormoisturizing the prongs 16 and/or the cushion 14.

In an alternative embodiment, as shown in FIG. 4-2, the frame 12 mayinclude one or more chin grabbing flaps 59. The one or more chingrabbing flaps may be retrofit to the frame 12. The one or more chingrabbing flaps may be elastic to improve fit and/or seal of the cushion14, or the one or more chin grabbing flaps may be configured to stopjaw-drop.

2.4 Prongs

The nasal prongs or nasal pillows 16 of the HYBRID™ mask 10 each includea single-wall head portion 60 adapted to provide a seal with thepatient's nasal passage and a base portion 62 adapted to be mounted tothe cushion 14. The base portion 62 is formed with rings 64 defining atleast one groove 66 therebetween. The cushion 14 includes two portals 68that define flanges adapted to engage a respective groove 66 to securethe prong 16 in position (e.g., see FIGS. 1-4, 1-5, 1-11, and 1-12).

2.4.1 Dual Wall Prongs

In an alternative embodiment, as shown in FIG. 5-1, each nasal prong 16may include a dual or double wall head portion 60 (e.g., inner and outerwalls 61, 63) to enhance the seal of the head portion 60 against thepatient's nare. An exemplary dual wall nasal prong is described in U.S.patent application Ser. No. 10/584,711, filed Jun. 26, 2006, and PCTApplication No. PCT/AU2006/000770, filed Jun. 6, 2006, each of which isincorporated herein by reference in its entirety.

In another alternative embodiment, the head portion 60 of each prong mayinclude more than two walls, e.g., three or more walls.

2.4.2 Trampoline-Like Base

In an alternative embodiment, each nasal prong 16 may include atrampoline-like base portion. Specifically, as shown in FIG. 5-1, thewall section within the grooves 66 may be thinned, e.g., thinnedsilicone, and the connecting bar 65 joining the prongs 16 may removed orcut to allow each nasal prong 16 to rotate and/or articulate about thebase portion (as indicated by the arrows). An exemplary trampoline-likebase is described in U.S. patent application Ser. No. 10/584,711, filedJun. 26, 2006, and PCT Application No. PCT/AU2006/000770, filed Jun. 6,2006, each of which is incorporated herein by reference in its entirety.

2.4.3 Alignment Indicators

In an alternative embodiment, one or more alignment indicators may beadded to the prongs 16 and/or cushion 14 to aid alignment of the prongs16 with respect to the cushion 14. For example, alignment indicators 75may be provided to the prongs 16 (see FIG. 5-7) that are adapted to bealigned with respective alignment indicators 77 provided to the cushion14 (see FIG. 6-3). An exemplary alignment indicator is also described inU.S. Provisional Patent Application No. 60/848,360, filed Oct. 2, 2006,which is incorporated herein by reference in its entirety.

2.4.4 Prong Angle

In an alternative embodiment, the prong 16 may be configured to extendat different prong angles as the prong 16 is rotated. For example, asschematically shown in FIG. 5-2, the prong 16 may include a camarrangement or leveling device including an sloped end 70 that isadapted to engage a sloped base 72, e.g., provided to the cushion 14.When the prong 16 is rotated, the sloped end 70 moves relative to thesloped base 72 which changes the angle at which the prong 16 extends.

As shown in FIG. 5-3-1, the grooves 66 in each HYBRID™ prong 16 arealigned with a horizontal axis of the prong 16. In another alternativeembodiment, one or more grooves 66 in the base portion of the prong 16may be configured to position the prong 16 at an angle. For example, asshown in FIG. 5-3-2, a groove 66A may be sloped with respect to ahorizontal axis of the prong 16 which is adapted to position the prong16 at an angle when mounted to the cushion 14 (see FIG. 5-3-3).

2.4.5 Other Prong Alternatives

In an alternative embodiment, the wall thickness of each prong may bereduced, e.g., to about 0.5 mm.

In an alternative embodiment, each prong 16 may be rotatable relative tothe cushion 14, and the prong rotation may include indexing orincremental stops.

In an alternative embodiment, as shown in FIG. 5-4, each prong 16 mayhave a drinking straw style concertina configuration 74 along its stalkand/or base portion to provide angle adjustment of the prong 16. Such anarrangement is disclosed in U.S. patent application Ser. No. 10/584,711,filed Jun. 26, 2006, which is incorporated herein by reference in itsentirety.

In an alternative embodiment, as shown in FIG. 5-5, each prong 16 mayhave one or more detents 76 to provide relatively large angle adjustmentof the prong 16.

In an alternative embodiment, the base of each prong 16 may include agimble or universal joint for adjustment.

In an alternative embodiment, each prong 16 may have a preload toprovide a sealing force with the patient's nare.

In an alternative embodiment, one or more of the rings 64 at the baseportion of each prong 16 may be sized such that the prong 16 cannot pushthrough the respective portal in the cushion 14. For example, FIG. 5-6illustrates a prong 16 wherein the uppermost rings 64 are sufficientlylarger than the portals in the cushion 16.

In an alternative embodiment, as shown in FIG. 5-7, the connecting bar65 joining the prongs 16 may be provided at the bottom edge of the prongbase portions, e.g., to avoid patient's septum. Such an arrangement isdisclosed in PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006,which is incorporated herein by reference in its entirety.

In an alternative embodiment, as shown in FIG. 5-8, each prong 16 mayinclude one or more stiffening members 78.

2.5 Cushion

The cushion 14 of the HYBRID™ mask 10 includes a chin portion or chinflap 80, an upper surface defining two portals 68 adapted to mountrespective nasal prongs 16, a face-contacting portion having a doublewall configuration (e.g., membrane 82 and undercushion 84), and anon-face-contacting portion having a leading edge 86 adapted to engage agroove 88 provided to the frame 12 to secure the cushion 14 to the frame12 (e.g., see FIGS. 1-9 to 1-11).

2.5.1 Cushion Profile

As shown in FIG. 6-1-1, the profile of the HYBRID™ cushion 14 isgenerally J-shaped. In an alternative embodiment, as shown in FIG.6-1-2, the cushion profile may have a question-mark or sickle shape. Thequestion-mark or sickle shape may provide the cushion with greater rangeof movement or flexibility towards the patient's face in use. Anexemplary cushion with a question-mark or sickle shape profile isdescribed in PCT Publication No. WO 2006/074513, published Jul. 20,2006, which is incorporated herein by reference in its entirety.

2.5.2 Gusset

In an alternative embodiment, as shown in FIG. 6-2, the cushion 14 mayinclude a gusset arrangement 85 to provide a reduced height profile,increased stability, better fit to the patient's face, and/or a reducedvisual impact.

An exemplary cushion with a gusset is described in U.S. patentapplication Ser. No. 10/655,622, filed Sep. 5, 2003, which isincorporated herein by reference in its entirety.

2.5.3 Cushion to Frame Interface

The leading edge of the HYBRID™ cushion is a substantially flat wall,which may easily disengage from the groove in the frame, e.g.,especially when greasy. In an alternative embodiment, a lip, lug, bead,and/or or rib may be provided to the leading edge of the cushion tobetter retain the cushion to the frame. Such retaining structures aredisclosed in U.S. patent application Ser. No. 10/390,682, filed Mar. 19,2003, which is incorporated herein by reference in its entirety.

2.5.4 Other Cushion Alternatives

In an alternative embodiment, the face-contacting portion may includemore than two walls, e.g., membrane 82 and two or more undercushions 84.

In an alternative embodiment, the cushion may have a preload to providea sealing force.

In an alternative embodiment, one or more alignment indicators may beadded to the cushion 14 and/or frame 12 to aid alignment of the cushion14 with respect to the frame 12. For example, FIG. 8-2 illustrates analignment indicator 87 provided to the frame 12 that is adapted to bealigned with a respective alignment indicator 89 provided to the cushion14. Such alignment indicators are also disclosed in U.S. patentapplication Ser. No. 10/390,682, filed Mar. 19, 2003, which isincorporated herein by reference in its entirety.

In an alternative embodiment, the chin flap 80 may be adjustable, e.g.,indexed or incremental adjustment. In an embodiment, as shown in FIG.6-3, the chin flap may include a bellows arrangement 85 to allowmovement of the chin in use.

In an alternative embodiment, the chin flap 80 may include multiple chinsupports.

In an alternative embodiment, cheek supports may be provided to thecushion 14, e.g., cheek wings, such as the cheek support shown in FIG.4-2.

In an alternative embodiment, the cushion may be configured or shaped toaccommodate the patient's septum and/or nasal bridge. Such cushionarrangements are disclosed in U.S. patent application Ser. No.10/390,682, filed Mar. 19, 2003, and U.S. Pat. No. 6,112,746, each ofwhich is incorporated herein by reference in its entirety.

2.6 Elbow Assembly

The elbow assembly 18 of the HYBRID™ mask 10 includes an elbow 90 and aswivel coupling 92 provided to the elbow 90. The elbow 90 includes afirst portion 94 attachable to the frame 12 and a second portion 96attachable to the swivel coupling 92. Also, the elbow 90 includes a port98 that is selectively closed by an anti-asphyxia valve 99 (e.g., seeFIGS. 1-3 to 1-5 and 1-9).

2.6.1 Shortened Length

As shown in FIGS. 1-3 to 1-5, the second portion 96 of the HYBRID™ elbow90 is substantially longer than the first portion 94. In an alternativeembodiment, as shown in FIG. 7-1, the second portion 96 of the elbow 90may be shortened to improve stability.

2.6.2 Tolerances

In the commercial embodiment of the HYBRID™ mask 10, excessive noise iscaused by significant leakage through the elbow to frame interface. Inan alternative embodiment, the manufacturing tolerances of the elbow 90and/or frame 12 may be improved to reduce noise caused by leak throughthe elbow to frame interface.

2.6.3 Other Elbow Assembly Alternatives

In an alternative embodiment, as shown in FIG. 7-2, a relatively shortswivel coupling 93 may be provided to each end of the elbow 90 to allowgreater flexibility.

In another alternative embodiment, a swivel coupling 92 may be providedover the elbow 90 to reduce the size of the elbow 90.

In another alternative embodiment, the elbow to frame connection mayinclude a ball joint arrangement.

In another alternative embodiment, the frame 12 may include two gasentry ports 53, e.g., one on each side of the frame as shown in FIG.7-3. In use, one of the ports may be provided with a plug 95 and theother of the ports may be provided with an elbow assembly 18. Thepositions of the plug and the elbow assembly may be interchanged,according to preference. Thus, the mask 10 may be configurable betweentwo different configurations.

In another alternative embodiment, the elbow assembly may be constructedof materials to prevent “squeaking” in use.

In another embodiment, the swivel coupling may permanently attach to theelbow with a snap-fit, e.g., to prevent separation.

In another embodiment, the elbow may be structured to facilitate removalof the anti-asphyxia valve, e.g., for cleaning so that the mask issuitable for use by multiple patients. For example, the anti-asphyxiavalve may be attached to a removable clip member that is removablyattachable to the elbow. Exemplary anti-asphyxia valve assemblies aredisclosed in PCT Publication No. WO 2007/045008, published Apr. 26,2007, which is incorporated herein by reference in its entirety.

2.7 Vent Holes

The HYBRID™ frame 12 includes six vent holes 56 for CO₂ washout. Thevent holes 56 are positioned above the gas entry port 52 and alignedalong a horizontal axis (e.g., see FIGS. 1-5 and 1-9).

2.7.1 Size and Number

In an alternative embodiment, the size of each vent hole 56 may besmaller and the number of vent holes 56 provided to the frame 12 may beincreased, e.g., greater than six vent holes (e.g., 6-60 vent holes).Exemplary vent arrangements are disclosed in U.S. Pat. No. 6,581,594 andPCT Application Nos. PCT/AU2006/000770, filed Jun. 6, 2006, andPCT/AU2006/001507, filed Oct. 13, 2006, each of which is incorporatedherein by reference in its entirety.

2.7.2 Positioning

In an alternative embodiment, as shown in FIG. 8-1, the vent holes 56may be moved away from the gas entry port 52 and elbow 90 connectedthereto. This vent arrangement may provide less interference with theelbow 90 and therefore less noise in use. Such a vent arrangement isdisclosed in PCT Application No. PCT/AU2006/000770, filed Jun. 6, 2006,which is incorporated herein by reference in its entirety.

2.7.3 Vent Hole Direction

In the commercial embodiment of the HYBRID™ mask 10, the vent holes 56direct washout gas along a generally horizontal plane or axis of theframe 12. In an alternative embodiment, as shown in FIG. 8-2, the ventholes 56 may be configured to direct washout gas at an angle withrespect to the horizontal axis of the frame 12. In an embodiment, agrommet may be provided to one or more of the vent holes to directwashout gas at an angle.

In another alternative embodiment, as shown in FIG. 8-3, the vent holes56 may be configured such that washout gas enters each vent hole alongone path and exits each vent hole along another path.

2.7.4 Other Vent Alternatives

In an alternative embodiment, one or more vent holes for CO₂ washout maybe provided in the base of each nasal prong 16 and/or in the cushion 14.

In another alternative embodiment, as shown in FIG. 8-4, one or morevent holes for CO₂ washout may be provided to the port cap 55 thatcovers a respective supplemental oxygen port 54 of the frame 12, e.g.,vent and port cap integrated into one elastomeric component.

In another alternative embodiment, the two port cap 55 may be tetheredto one another, e.g., double ports cap. Such an arrangement is disclosedin U.S. Pat. No. 6,439,230, which is incorporated herein by reference inits entirety.

2.8 Miscellaneous

The following embodiments describe additional improvements and/oralternative arrangements of the HYBRID™ mask.

2.8.1 Forehead Support

In an alternative embodiment, as schematically shown in FIG. 8-4, aforehead support 99 may be provided to the HYBRID™ mask 10 to provide asupport and stability mechanism between the mask and the patient'sforehead. Exemplary forehead support arrangements are disclosed in U.S.Pat. Nos. 6,119,693 and 6,532,961 and PCT Application No.PCT/AU2006/000037, filed Jan. 12, 2006, each of which is incorporatedherein by reference in its entirety.

In an embodiment, the forehead support may include forehead pads thatextend up and around the outside of the patient's eyes. Exemplaryforehead pads are disclosed in U.S. patent application Ser. No.10/655,595, filed Sep. 5, 2003, which is incorporated herein byreference in its entirety.

In another embodiment, the forehead support may include a nose supportadapted to engage the nose and provide a support and stability mechanismbetween the mask and the patient's nose.

In another embodiment, the forehead support may include a cheek supportadapted to engage the patient's cheeks and provide a support andstability mechanism between the mask and the patient's cheeks, e.g.,such as the cheek support shown in FIG. 4-2.

2.8.2 Other Alternatives

In an alternative embodiment, the HYBRID™ mask 10 may include anintra-oral bite or dental insert provided within the patient's mouth. Inan embodiment, the insert may constitute a mandibular advancement devicestructured to advance the position of the patient's lower jaw. Anexemplary mandibular advancement device is disclosed in PCT ApplicationNo. PCT/AU2006/001095, filed Aug. 2, 2005, which is incorporated hereinby reference in its entirety.

In another alternative embodiment, the frame 12, cushion 14, nasalprongs 16, and/or headgear 20 of the HYBRID™ mask 10 may be constructedof a malleable material to allow bending for conformance to thepatient's head and/or face, e.g., conform mask to suit different faces.

In another alternative embodiment, the frame 12 and/or cushion 14 mayinclude an articulating feature that allows the jaw to move in use. Thearticulating feature may be adjustable and lockable.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, bariatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike.

1. A mask comprising: a frame; a facial and nasal interface provided tothe frame; and headgear provided to the frame to maintain the mask in adesired position on the patient's face, the headgear including at leastone strap and a buckle provided to the strap, the buckle including anopening adapted to engage a post provided on the frame, wherein theopening and/or the post includes a keyed portion structured to preventrotation of the buckle with respect to the post when the buckle isengaged with the post.
 2. A mask comprising: a frame; a facial and nasalinterface provided to the frame; and a lotion dispenser or moisturizerprovided to frame and adapted to dispense lotion for lubricating and/ormoisturizing the facial and/or nasal interface.
 3. The mask according toclaim 2, wherein the facial interface includes a cushion adapted to forma seal around an exterior of the patient's mouth in use.
 4. The maskaccording to claim 2, wherein the nasal interface includes nasal prongsadapted to from a seal with the patient's nasal passages in use.
 5. Amask comprising: a frame; a cushion provided to the frame and adapted toform a seal around an exterior of the patient's mouth in use; and nasalprongs provided to the cushion and adapted to from a seal with thepatient's nasal passages in use, wherein each of the nasal prongs isadapted to rotate relative to the cushion to change the angle at whichthe nasal prong extends with respect to the cushion.
 6. The maskaccording to claim 5, wherein each of the nasal prongs includes a slopedend that engages a sloped base provided to the cushion such thatrotation of the nasal prong is adapted to rotate the sloped end relativeto the sloped base which changes the angle at which the prong extendswith respect to the cushion.
 7. (canceled)